To evaluate the Safety and efficacy of Unani medicine in the treatment of inflammation of the mouth and lips (stomatitis)
- Conditions
- Other forms of stomatitis, QulÄ (Stomatitis),
- Registration Number
- CTRI/2015/03/005633
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
This study is designed as a multicentric open trial in patients with **Qulđ ( Stomatitis)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on 3rd and 7th day of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.
**Composition of PharmacopoeialFormulation ‘*****ZaroorKath*****’**
| | | | | |
| --- | --- | --- | --- | --- |
|**S. No.**
**Tibbi Name**
**Scientific Name**
**Parts used**
**Quantity**
|1
Zar-e- Ward
Rosa damascena Mill.
Pollen grains
1 part
|2
Kat Safed
Acacia catechu (Linn. f.) Willd.
Extract
-do-
|3
Dana Heel Khurd
Elettaria cardamomum (Linn.) Maton
Seeds
-do-
|4
Tabasheer
Bambusa arundinacea (Retz.) Roxb.
Siliceous secretion
-do-
|5
Kafoor
Cinnamomum camphora (Linn.) J. Presl
Extract
-do-
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 540
•Patients of either sex in the age group of 10-65 •Presence of single /multiple ulcers in the oral cavity and tongue With and without Presence of any of the following symptoms oDifficulty in eating/ chewing/Uneasiness in Speaking /Swallowing oBurning sensation / Pain in the mouth oExcessive salivation oCoated tongue.
•Disorders requiring long term treatment •Known cases of underlying systemic diseases such as crohn’s disease, ulcerative colitis, Celiac disease, lupus erythematosus, behcet’s disease, Cyclic neutropenia, immunodeficiency disorders •Known cases of carcinoma •Patients with hemoglobin level < 8 g /dl • Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in signs and symptoms of Qulđ ( Stomatitis) 7 days
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safety assessment 7 weeks
Trial Locations
- Locations (7)
Clinical Research Unit (CRU), Karimganj
🇮🇳Karimganj, ASSAM, India
Clinical Research Unit (CRU), Kurnool
🇮🇳Kurnool, ANDHRA PRADESH, India
Regional Research Centre (RRC), Silchar
🇮🇳Cachar, ASSAM, India
Regional Research Institute of Unani Medicine (RRIUM), Bhadrak
🇮🇳Bhadrak, ORISSA, India
Regional Research Institute of Unani Medicine (RRIUM), Chennai
🇮🇳Chennai, TAMIL NADU, India
Regional Research Institute of Unani Medicine (RRIUM), Mumbai
🇮🇳Mumbai, MAHARASHTRA, India
Regional Research Institute of Unani Medicine (RRIUM), Patna
🇮🇳Patna, BIHAR, India
Clinical Research Unit (CRU), Karimganj🇮🇳Karimganj, ASSAM, IndiaDR WAHIDUZZAMANPrincipal investigator03843267522crukxj522@gmail.com